|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170043 / PAS002 |
| Date Original Protocol Accepted |
04/16/2019
|
| Date Current Protocol Accepted |
03/03/2021
|
| Study Name |
New Enrollment PAS
|
| Device Name |
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
|
| Clinical Trial Number(s) |
NCT01461291
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this post approval study (PAS) is to evaluate the rate of clinically relevant complications associated with iStent inject
placement and stability, as determined at 36 months in the postmarket setting compared to the pre-specified performance
target of 2%. This is a prospective, non-randomized, multicenter, single-arm, post approval study of the iStent inject with follow-up
through 3 years postoperative.
|
| Study Population |
358 eyes at a minimum of 15 and up to 30 investigational sites in the U.S. It is expected that the enrollment phase will last up to 37.5
months.
|
| Sample Size |
A sample size of 250 eyes can provide a statistical power of 80% at a true p of 0.05. Considering a drop-out rate of 30% at 36 months for
this post-approval study, the study should treat at least 358 eyes of 358 subjects.
|
| Key Study Endpoints |
The rate of clinically relevant complications associated with iStent inject placement and stability as determined at 36 months.
Specific device-related complications include clinical sequelae resulting from device position including, but not limited to:
Secondary surgical intervention (SSI) to modify device position (e.g., repositioning or explantation)
Corneal endothelial touch by device
Corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit, in comparison with preoperative BSCVA
Other Safety Outcomes:
Rate of occurrence of sight-threatening adverse events including:
Persistent (at time of study exit) BSCVA loss greater than or equal to 3 lines compared to best recorded BSCVA at any postoperative visit
Endophthalmitis
Corneal decompensation
Retinal detachment
Severe choroidal hemorrhage or detachment or aqueous misdirection
Rate of ocular secondary surgical interventions (SSI)
Rate of other adverse events including:
Increase from baseline IOP of greater than or equal to 10 mmHg at any time greater than or equal to 30 days postoperative
BSCVA loss greater than or equal to 2 lines at Month 36 compared to preoperative
BSCVA loss greater than or equal to 2 lines at Month 36 compared to best recorded
BSCVA at any postoperative visit
Device movement, defined as a stent not visible in the original location, that does not result in clinically relevant complications
as described above (e.g., SSI to modify device position, corneal endothelial touch by device, or corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit compared to preoperative BSCVA), and that is not attributable to any one or more of the following:
variations in gonioscopy, OCT or UBM (or other standard imaging methods) viewing angle or illumination
changes in angle anatomy due to concomitant findings such as resolution of hyphema
changes in anterior chamber depth
development of focal peripheral anterior synechiae (PAS)
|
| Follow-up Visits and Length of Follow-up |
36 months (3 years)
|
